Today's pharmaceutical manufacturing is driven by one of two vastly different strategies: reducing costs or incorporating new technologies, such as Process Analytical Technology (PAT) or new drug delivery vehicles. Reducing costs can result in utilizing unfamiliar raw material suppliers, which can result in unplanned process variability or process changes. Perhaps you are on the other side of this relationship, whereby you are unsure if your process changes will affect your customer.

On the other hand, newer materials and manufacturing techniques demand a better understanding of the process as a whole. This may include implementing various programs such as six sigma, PAT, quality by design, or specific FDA guidance documents, with the goal of improved quality and reduced time-to-market. Novel techniques can pose increased risk and effort to implement.

Jenike & Johanson can provide you with knowledge of how powders will behave from raw material dispensing, blending, storage, transfer, and through the creation of the final dose. This knowledge can be used to avoid and solve problems related to erratic or no-flow conditions, as well as segregation , blend and content uniformity.

Review our new service regarding analyzing production rate limitations

KEY ENGINEERING SERVICES

• Characterization of materials (raw ingredients and blends) during formulation development to predict manufacturability at full-scale
• Design and selection of appropriate bins, blenders, chutes, and hoppers
• Techniques to avoid erratic flow and weight variations, especially at high speed tableting and capsule filling machines
• Unique feeding and dispensing techniques for light, sticky, and/or cohesive materials
• Addressing build-up on material surfaces
• Controlling active losses during manufacturing
• Development of specialized testing techniques for R&D and QC /batch release
• Development of sampling protocols and uniformity acceptance criteria
• Conducting statistical analysis of batch data (blend uniformity data, content uniformity data)

In order to formulate an approach to solving or preventing a problem, we need to learn as much as possible about your application to ensure that handling problems do not occur with the new equipment.

TYPICAL PROJECT APPROACH

• Plant visit for troubleshooting, understanding plant requirements, and process auditing
• Flow properties testing of bulk solids
• Root cause analysis of handling/feeding/conveying problems
• Functional design of solids handling equipment
• Detailed engineering design of equipment
• Supply of custom designed equipment

For over forty years, our team of experienced engineers has been providing proven technology solutions that are cost-effective and safe. Contact Jenike & Johanson to help you solve and prevent bulk solids handling problems.